Cummings and colleagues presented appropriate use criteria for the newly approved Biogen/Eisai agent at the 2021 Alzheimer’s Association International Conference.
Since its approval on June 7, 2021, aducanumab (Aduhelm; Biogen/Eisai) has maintained its place as a major hot topic in the conversations among those in the field of Alzheimer disease (AD) and dementia. Particularly, those conversations have in part focused on which individuals are best suited for treatment with the antiamyloid infusion therapy.
Shortly after its approval, the FDA announced an update to the drug’s label, stating that treatment with aducanumab should be initiated in patients with mild cognitive impairment or mild dementia stages of the disease, the population in which the treatment was initiated in clinical trials. It continues to state that there are no safety or efficacy data on initiating treatment at earlier or later stages of the disease than were studied. Despite this, there remains a need to educate physicians on the identification of these patients and the complexities of the therapy.
At the 2021 Alzheimer Association International Conference (AAIC), July 26-30, a number of physicians presented appropriate use criteria for aducanumab in order to clarify some of these lingering questions, which were published in The Journal of Prevention of Alzheimer's Disease prior to the meeting. Among them was Jeffrey L. Cummings, MD, ScD, professor of brain science, and director, Chambers-Grundy Center for Transformative Neuroscience, University of Nevada–Las Vegas.
Jeffrey L. Cummings, MD, ScD: People have wondered how these criteria came about and why we would provide appropriate use criteria for a drug that has just been approved. The group that I was working with looked at the package insert that was approved on June 7 and saw that there was not sufficient detail for clinicians who were unfamiliar with aducanumab to actually know how to take the first, second, and third steps to initiate an aducanumab treatment program. So, we put together an appropriate use committee that has produced these appropriate use recommendations.
They deal very seriously with safety, how to manage the ARIA [amyloid-related imaging abnormalities] and the safety of aducanumab, and how to choose the patient for aducanumab—because we want to keep those patients very close to the trial patients in terms of their characteristics—and then how to talk with the patients. This is a complicated drug. The patient has to commit themselves to monthly infusions, they have to commit themselves to frequent MRI scanning in the first year, they have to know that ARIA occurs and that it can be a symptomatic outcome of the treatment with aducanumab. The shared decision-making between the clinician and the patient is extremely important for this particular agent, and we emphasize that a lot in terms of the appropriate use recommendations.
I think the education of the physician is going to be a tremendously important part of this rollout in order to make the use of aducanumab both proper and safe. What we've heard already is that our appropriate use recommendations are being taken by the pharmacy committees of hospitals to help guide how their programs should be constructed. Once the programs have a kind of infrastructure established, then the physician education can begin to provide the know-how about moving the drug out, talking with patients about it, administering it, and monitoring it. I see this as a stepwise process, beginning with the pharmacy committees and then eventually going out to both patient education and physician education.
Well, I rarely deal with the price or cost of drugs, but in this case, of course, that is a major question. Will Medicare provide coverage for aducanumab and other monoclonal antibodies that we think will be coming out from other companies? That answer is currently unclear. CMS has given it a lot of thought at this point to decide how coverage should occur and how they would decide to cover it. That's a critical issue, and it is critical for doctors and healthcare systems. That will have to be resolved before we'll be able to have complete use of aducanumab for the appropriate patients.
The blood tests for Alzheimer disease are just making so much great progress and are going to be so informative in a whole variety of ways. Diagnostic confirmation, the identification of different types of pathology—is it the amyloid measures that are changing, is it the tau measures that are changing, or is it the neurofilament light that reflects neurodegeneration that's changing? We're going to get so much information. Do they reflect the therapeutic response? When do we remove amyloid? Do we change the blood factors—we're not quite sure of that yet. Could we decide when to stop treatment, or could we decide when to restart treatment if it has been stopped? These are all just great questions, and I think they're going to be driven much more by the biomarkers than they are by our clinical assessments. These blood tests are just going to be a wonderful assistance to physicians.
Transcript edited for clarity. For more coverage of AAIC 2021, click here.